CBER’S Advanced Technologies Program (ATP) is being strengthened through the expansion of internal and external funding, scientific and regulatory expertise, and collaborative support through the CBER Advanced Technologies Team (CATT).
As part of its efforts to promote the adoption of advanced manufacturing, CATT has joined with CDER’s Emerging Technologies Team (ETT) to form the Center for the Advancement of Manufacturing Pharmaceuticals and Biopharmaceuticals (CAMPB). The Office of Regulatory Affairs and other centers are also expected to participate in the center’s activities.
The aims of the CAMPB are to: ● accelerate the development, implementation, and evaluation of advanced manufacturing by establishing science- and risk-based standards and policies ● advance drug product development science, and ● train a world-leading regulatory workforce through strategic partnership, engagement, and communication.
In mid-September, the US FDA’s India office in partnership with DIA hosted a two-day online workshop to explore the regulatory policies, guidance, and other support now being directed at advanced manufacturing. Perspectives were provided by the CDER and CBER advanced technologies teams, Japan’s PMDA, Australia’s TGA, India’s CDSCO, and industry.
CBER Office of the Director Senior Scientist Manuel Osorio, who leads the CATT, spoke about: ● the definition and benefits of advanced manufacturing ● the CBER ATP, and ● other center activities to support advanced manufacturing. Osorio is part of the team working to implement the CDER-led Framework for Advanced Manufacturing Evaluations (FRAME) initiative. [Osorio’s full comments are appended below. See Part IV of IPQ August 28, 2022 for more on FRAME and its goals.]